Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDIVANCE, INC. ¿ 1725056 ARCTIC SUN® 5000; ARCTIC SUN DEVICE
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

MEDIVANCE, INC. ¿ 1725056 ARCTIC SUN® 5000; ARCTIC SUN DEVICE Back to Search Results
Catalog Number 50000000E
Device Problems Insufficient Heating (1287); Use of Device Problem (1670)
Patient Problem Chills (2191)
Event Date 10/12/2023
Event Type  malfunction  
Event Description
It was reported that the patient had been rewarming since 5:40 yesterday in an arctic sun device, but nurse noted patient temperature (pt) was now dropping below the targeted temperature (tt) , patient temperature (pt) was 35.9c, targeted temperature (tt) was 37c, water temperature (wt) was 11.6c, water flow rate (wfr) was 3.1 l/m.4 pads attached with some exposed abdomen.They have changed the targeted temperature (tt) a couple of times trying to get water temperature (wt) to increase.Patient was shivering.Discussed importance of pad coverage and suggested adding universal pad to cover abdomen.Also discussed addressing shivering.Noted use of bair huggers or warm blankets was not contraindicated per their ifu, but to default to their protocol.Verified rewarm patient box was flashing.System diagnostics showed that the outlet monitor temperature (t1) was 7.7c, outlet control temperature (t2) was 7.8c, inlet temperature (t3) was 9.9c, chiller temperature (t4) was 5.9c, water flow rate (wfr) was 2.8 l/m, inlet pressure (ip) was -7 psi, circulation pump command (cpc) was 82 percentage, mixing pump command (mpc) was 100 percentage, heater command (hc) was 0, water reservoir level (wrl) was 5, system hours were 2677.2 and pump hours were 2273.7.Rewarm patient reads from 33c at 0.45c/hr to targeted temperature (tt) was 37c.Had them stop therapy, adjust cool to patient temperature (pt) was to current patient temperature (pt) of 35.9c.Verified rewarm patient box rewarm from 35.9c at 0.45c/hr to 37c.Restarted therapy under rewarm patient.Water temperature (wt) was immediately began rising.After a couple of minutes system diagnostics showed that the outlet monitor temperature (t1) was 19.8c, outlet control temperature (t2) was 19.1c, inlet temperature (t3) was 16.3c, chiller temperature (t4) was 4.5c, water flow rate (wfr) was 2.8 l/m, inlet pressure (ip) was -7.1 psi, circulation pump command (cpc) was 82 percentage, mixing pump command (mpc) was 0, heater command (hc) was 100 percentage.Noted heater was now engaged and water was warming up.Advised to monitor water temperature (wt) was over the next 30 minutes to an hour.If water temperature (wt) did not increase to upper 30s, then call back for additional assistance.
 
Manufacturer Narrative
The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.H11: section a through f - the information provided by bd represents all the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.H3 other text : the device was not returned.
 
Event Description
It was reported that the patient had been rewarming since 5:40 yesterday in an arctic sun device, but nurse noted patient temperature (pt) was now dropping below the targeted temperature (tt) , patient temperature (pt) was 35.9c, targeted temperature (tt) was 37c, water temperature (wt) was 11.6c, water flow rate (wfr) was 3.1 l/m.4 pads attached with some exposed abdomen.They have changed the targeted temperature (tt) a couple of times trying to get water temperature (wt) to increase.Patient was shivering.Discussed importance of pad coverage and suggested adding universal pad to cover abdomen.Also discussed addressing shivering.Noted use of bair huggers or warm blankets was not contraindicated per their ifu, but to default to their protocol.Verified rewarm patient box was flashing.System diagnostics showed that the outlet monitor temperature (t1) was 7.7c, outlet control temperature (t2) was 7.8c, inlet temperature (t3) was 9.9c, chiller temperature (t4) was 5.9c, water flow rate (wfr) was 2.8 l/m, inlet pressure (ip) was -7 psi, circulation pump command (cpc) was 82 percentage, mixing pump command (mpc) was 100 percentage, heater command (hc) was 0, water reservoir level (wrl) was 5, system hours were 2677.2 and pump hours were 2273.7.Rewarm patient reads from 33c at 0.45c/hr to targeted temperature (tt) was 37c.Had them stop therapy, adjust cool to patient temperature (pt) was to current patient temperature (pt) of 35.9c.Verified rewarm patient box rewarm from 35.9c at 0.45c/hr to 37c.Restarted therapy under rewarm patient.Water temperature (wt) was immediately began rising.After a couple of minutes system diagnostics showed that the outlet monitor temperature (t1) was 19.8c, outlet control temperature (t2) was 19.1c, inlet temperature (t3) was 16.3c, chiller temperature (t4) was 4.5c, water flow rate (wfr) was 2.8 l/m, inlet pressure (ip) was -7.1 psi, circulation pump command (cpc) was 82 percentage, mixing pump command (mpc) was 0, heater command (hc) was 100 percentage.Noted heater was now engaged and water was warming up.Advised to monitor water temperature (wt) was over the next 30 minutes to an hour.If water temperature (wt) did not increase to upper 30s, then call back for additional assistance.
 
Manufacturer Narrative
Upon further review of investigation, bd has determined that this mdr is not reportable.H11: section a through f - the information provided by bd represents all the known information at this time.Despite good faith efforts to obtain additional information, the complainant/reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.H3 other text: the device was not returned.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
ARCTIC SUN® 5000
Type of Device
ARCTIC SUN DEVICE
Manufacturer (Section D)
MEDIVANCE, INC. ¿ 1725056
321 s taylor ave
suite 200
louisville 80027
Manufacturer (Section G)
MEDIVANCE, INC. ¿ 1725056
321 s taylor ave
suite 200
louisville 80027
Manufacturer Contact
xeeroy rada
8195 industrial blvd
covington 30014
7707846100
MDR Report Key18056042
MDR Text Key327172286
Report Number1018233-2023-07790
Device Sequence Number1
Product Code DWJ
UDI-Device Identifier00801741127755
UDI-Public(01)00801741127755
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K161602
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Health Professional,User Facility
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 01/17/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/02/2023
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number50000000E
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received01/17/2024
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
Patient Outcome(s) Other;
-
-